Kornimate/medical-research-clean huggingface dataset:
influence of ethnical differences on the egg cell collected in patients undergoing fertility treatment

Conditions: Infertility

Summary: investigators wants to analyze the differences considering the country of origin, ethnicity, characteristics, reproductive history and habits of participants undergoing in vitro fertilization (ivf) / intracytoplasmic sperm injection (icsi) treatment as well as the stimulation outcome in regards to stimulation dosages and egg cell yield.

infertility is acknowledged worldwide as a major health concern with significant regional differences. the prevalence of infertility in women of reproductive age has been estimated to be one in every seven couples in the western world and one in every four couples in developing countries. geographical, sociocultural / religious and ethnical dissimilarities contribute to these global variations in infertility prevalence. infertility has a major impact on family stability in many cultures, especially in developing countries, where childlessness can impact sociocultural status. so far, most fertility treatments are based on studies performed in western countries and therefore mostly performed in caucasian population and research regarding infertility causes and optimal treatments in other populations is scarce. the aim of this prospective study is therefore to analyze the differences in the basic parameters of the populations analyzed, considering the country of origin and ethnicity undergoing ivf/icsi treatment as well as the stimulation outcome in regards to stimulation dosages and oocyte yield.

Eligibility criteria:
inclusion criteria: • couples with primary / secondary infertility who are planned to undergo ivf / icsi treatment in one of the above mentioned centers and who agree to take part in this study. exclusion criteria: * couples planned for oocyte and sperm donation * couples in whom the female partner has a history of: * chemotherapy or radiation which impacts the ovarian reserve * surgery at the ovaries / adnex region * tubal ligation * reversal of tubal ligation * endometriosis * couples in whom the male partner has a history of: * chemotherapy / radiation which impacts the semen result * surgery at the testicles * vasectomy * surgery for reversal of vasectomy

Keywords: oocyte yield ethnicity ovarian stimulation
stall vs sole local wound infiltration in laparoscopic cholecystectomy

Conditions: Cholelithiasis; Cholecystitis; Gallbladder Cancer

Summary: this trial is a prospective randomized superiority trial comparing sole ropivacaine based local trocar site infiltration to local infiltration combined with laparoscopic ropivacaine tap block (stall) in lcc. there are only a few randomized trials comparing sole local anesthesia to additional laparoscopic tap block in laparoscopic cholecystectomy and they have yet failed to show evidence in favor of tap block. we hypothesize stall (single transversus abdominis laparoscopy-guided plane block combined with local trocar site ropivacaine infiltration) is superior to local port site infiltration, provided that the sample size is sufficiently big. the aim of this randomized study is to compare the efficacy of sole local anesthesia of trocar sites to stall in lcc.


Eligibility criteria:
inclusion criteria: * all patients scheduled for elective or emergency lcc, aged over 18 and able to give an informed consent. exclusion criteria: * age under 18 years, chronic daily opioid and/or pain tolerance / pain threshold -modifying medication use (abuse), pregnancy, known allergy to local anesthetics, diagnosed severe coagulopathy and incapability to give informed consent for whatever reason.

Keywords: laparoscopic transversus abdominis plane block
mdr - comprehensive primary revision stems pmcf

Conditions: Shoulder Pain; Shoulder Injuries; Shoulder Fractures; Shoulder Disease; Shoulder Arthritis

Summary: the objective of this retrospective and prospective consecutive series pmcf (post market clinical follow up) study is to collect long-term data confirming safety, performance and clinical benefits of the comprehensive primary revision stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.

the safety of this device will be assessed by analyzing implant survivorship. this will be established by recording the incidence and frequency of revisions, complications, and adverse events. relation of the events to implant, instrumentation and/or procedure should be specified. the performance will be evaluated by assessment of reported clinical outcome measures (proms) as well as radiographic outcomes.

Eligibility criteria:
inclusion criteria * patient must be 18 years of age or older. * patient must be willing and able to follow directions. * study devices must have been implanted following the surgical technique and ifu for the comprehensive revision stem exclusion criteria * off-label use. * patient is a prisoner. * patient is a current alcohol or drug abuser. * patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent. * patient is unwilling to sign informed consent. * uncooperative patient or patient with neurologic disorders who are incapable of following directions.
safety, tolerability, and efficacy of aflibercept in patients with neovascular age-related macular degeneration

Conditions: Neovascular (Wet) Age-Related Macular Degeneration

Summary: the primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as hd) and to determine if hd provides greater intraocular pharmacodynamic (pd) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as iai).


Eligibility criteria:
key inclusion criteria: * men or women ≥50 years of age with active subfoveal choroidal neovascularization (cnv) secondary to namd * best corrected visual acuity (bcva) early treatment diabetic retinopathy study (etdrs) letter score of 78 to 24 (snellen equivalent of 20/32 to 20/320) in the study eye key exclusion criteria: * evidence of cnv due to any cause other than namd in either eye * evidence of diabetic macular edema (dme) or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients * prior use of ivt anti-vegf agents (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) in the study eye * prior ivt investigational agents in either eye (eg, anti-ang-2/anti-vegf bispecific monoclonal antibodies, gene therapy) * previous use of intraocular or periocular corticosteroids within 120 days of screening or treatment with an ivt steroid implant at any time in the study eye * history of vitreoretinal surgery (including scleral buckling) in the study eye * any other intraocular surgery within 12 weeks (84 days) before the screening visit * history of corneal transplant or corneal dystrophy in study eye note: other protocol defined inclusion/exclusion criteria apply.
bioequivalence study of rosuvastatin in healthy volunteers under fasting condition

Conditions: Bioequivalence

Summary: the present study is conducted to evaluate and compare the relative bioavailability for rosuvastatin in two different products containing 10 mg film coated tablet after single oral administration.

a randomized, single-dose, two-way crossover, open-label, bioequivalence study of the two different products containing 10 mg film coated tablet after oral administration to 38 healthy adult volunteers under fasting conditions. blood samples were collected at different time intervals and stored at -70⁰c freezer. plasma concentrations of rosuvastatin were analyzed and determined using a validated lc-ms-ms method then pharmacokinetics and statistical analysis were performed.

Eligibility criteria:
inclusion criteria: * written informed consent is obtained for study. * age 18 - 55 years, * body mass index between 18.5 and 30 kg/m2 * have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination. * vital signs without significant deviations. * all laboratory screening results are within the normal range or clinically non-significant exclusion criteria: * history or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator. * history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer. * any confirmed significant allergic reactions against any drug, or multiple allergies. * clinically significant illness 28 days before study phase i. * alcohol or any solvent intake. * regular use of medication. * positive urine screening of drugs of abuse. * use of any systemic medications (prescription medications, otc products, supplements, or herbal preparations) for 14 days prior to dosing and during the study. * history or presence of significant smoking (more than one pack per day cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout. * blood donation within the past 60 days. * participation in another bioequivalence study within 60 days prior to the start of phase i of the study.

Keywords: rosuvastatin bioequivalence randomized cross-over
a study to assess health-related quality of life in patients with hypertrophic cardiomyopathy in japan

Conditions: Hypertrophic Cardiomyopathy

Summary: this cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in japan. the study consists of two phases. phase i is a qualitative study using semi-structured in-depth interviews in participants with hypertrophic cardiomyopathy. phase ii is a quantitative study using questionnaires in participants with hypertrophic cardiomyopathy and a control group of participants who do not have hypertrophic cardiomyopathy.


Eligibility criteria:
inclusion criteria - hypertrophic cardiomyopathy group * participants diagnosed with non-obstructive or obstructive hcm in japan * participants aged ≥18 years of age * participants who have been attending outpatient visits for hcm and who are referred to the study by the physician treating hcm * participants with hcm who are diagnosed as new york heart association (nyha) functional classification 2-3 at enrolment * participants experiencing burden in their daily lives because of hcm (self-reported) inclusion criteria - control group * participants aged ≥18 years of age * individuals from the general population who are enrolled in 3h clinical trial's consumer panel exclusion criteria - hypertrophic cardiomyopathy group * participants who have ever been diagnosed with dilated cardiomyopathy or secondary cardiomyopathy, including cardiac amyloidosis, fabry disease, or mitochondrial myopathy * participants who have previously participated or are currently participating in another clinical trial (not including observational studies) exclusion criteria - control group * participants who have ever been diagnosed with non-obstructive or obstructive hcm * participants who have ever been diagnosed with either dilated cardiomyopathy or secondary cardiomyopathy, including cardiac amyloidosis, fabry disease, or mitochondrial myopathy * participants who have previously participated or are currently participating in another clinical trial (not including observational studies)
use of prineo in breast reduction surgery

Conditions: Efficiency of Surgical Incision Closure; Post-operative Scar

Summary: this is a prospective, randomized, controlled, single-blinded study to compare prineo™ with subcuticular sutures in 20 women undergoing bilateral breast reduction. for each patient, the final skin layer of one breast will be closed with subcuticular suture while the other breast will be closed with prineo™. the treatment will be randomized to left or right breast. therefore, the investigators will have 20 breasts in the suture group and 20 in the prineo™ group, with each patient serving as her own control. for this study, the resident will close one side with suture and dr. rohde will apply the prineo. the investigators will perform this study of incision closure under conditions as similar to normal conditions of closure.

wound closure with dermal sutures is time consuming and may increase risk of infection and inflammation. moreover, appearance of the resulting scar depends largely on surgeon technique. use of the prineo™ wound closure system may decrease operative time, decrease incidence of infection and inflammation, and improve aesthetics of the resulting scar. prineo™ has been shown to hold as well as sutures for the first 12-25 days and may reduce closure time of the final skin layer up to 75% in abdominoplasty and breast procedures. the system provides excellent coverage of the wound edge, protecting the incision with a microbial barrier. cosmetic results in abdominoplasty and breast procedures appear to be equivalent to sutures. the main endpoints will be operative time to closure of the final skin layer and patient-rated and blinded observer-rated scar quality. the investigators hypothesize that operative time to closure of the final skin layer using prineo™ will be faster than operative time to closure using subcuticular suture. the investigators also hypothesize that subjective and objective scar quality of incisions closed with prineo™ will be better than those closed with subcuticular suture.

Eligibility criteria:
inclusion criteria: * women undergoing wise pattern breast reductions for symptomatic macromastia. exclusion criteria: * subjects who have an allergy to cyanoacrylate, formaldehyde, surgical tape, or any other known component of the prineo system will be excluded. * subjects who refuse to be photographed or refuse to have their scars assessed by a blinded plastic surgeon will be excluded.

Keywords: wound closure prineo scar
ovarian reserve in women with cystic fibrosis and the correlation with demographic and clinical parameters

Conditions: Cystic Fibrosis; Infertility, Female

Summary: the main objective of this study is to assess the ovarian reserve of cf patients via measurement of amh and afc. secondly, we aim to correlate between the ovarian reserve and demographic and clinical characteristics of these patients. outcomes measured will be levels of amh and afc, as compared to standard means in the general population. there is no need for a control group in this study since the standardized means of amh and afc in the general population are a more accurate comparable measure, which is based on data collected from large-scale populations, and thus accounts for confounding age factor in a more complete manner than can be obtained via a control group (almog et al., 2011, la marca et al., 2012, penzias et al., 2020).


Eligibility criteria:
inclusion criteria: * female patients diagnosed with cf according to genetic testing. * age 18-45 years old. * routinely attended the cf center at hadassah medical center. exclusion criteria: * refusal to participate in the study. * age under 18 or above 45. * use of hormonal contraceptives (for the purpose of afc).

Keywords: antral follicular count anti-mullerian hormone
a study of ave8062 in advanced-stage soft tissue sarcoma after failure of anthracycline and ifosfamide chemotherapies

Conditions: Sarcoma

Summary: the primary objective of the study is to compare the progression-free survival (pfs) in the 2 treatment arms the secondary objectives of the study are : * to compare the overall survival in the 2 treatment arms * to compare the objective response rate in the 2 treatment arms * to assess the safety profile of ave8062 (in combination with the background cisplatin therapy) * to assess the pharmacokinetics of ave8062 and its main metabolite, rpr258063, using a population approach, in all patients enrolled in selected centers.


Eligibility criteria:
inclusion criteria: * histologically proven soft tissue sarcoma * unresectable locoregional recurrent or metastatic soft tissue sarcoma * failure of a previous anthracycline-based regimen administered recommended dose and of prior ifosfamide therapy exclusion criteria: * less than 3 weeks elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization * brain metastases and carcinomatous leptomeningitis * uncontrolled hypertension * known platinum hypersensitivity the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: tubulin modulator endothelium combretastatin cisplatin
influence of different light dose on the adverse effect of swallowing for esophageal carcinoma

Conditions: Esophagus Cancer

Summary: the purpose of this experiment is to study the alleviating effects and side effects of different laser irradiation doses on esophageal stricture of esophageal cancer in order to find the appropriate dose of light.

background: photodynamic therapy (pdt) is one of the effective means for the control of esophageal stenosis in advanced esophageal cancer, among which the dose intensity of laser irradiation is one of the factors affecting the efficacy. this study aims to pursue the appropriate dose of light. aim: to compare the efficacy and safety of two groups of different laser irradiation doses for advanced esophageal cancer and esophageal stricture. methods: fifty-seven patients were recruited for this study and randomly divided into two groups: single irradiation group and reirradiation group.single irradiation group: 46-48h irradiation after photosensitizer injection: power density: 200mw·cm-2, irradiation time: 900s, volume density: 180 j·cm-2;double irradiation group: 46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mw·cm-2, irradiation time: 900s, volume density: 180 j·cm-2;power density: 200mw·cm-2, irradiation time: 300s, volume density: 60 j·cm-2. primary endpoints: orr rates at 1 and 3 months, the quality of life

Eligibility criteria:
inclusion criteria: * esophagus cancer * 18-80 years old * grade 3-4 dysphagia （stoller classification） * non-eradicative second-line treatment exclusion criteria: * ulcerative tumor * esophageal stenosis caused by radiotherapy * survival is less than 3 months * patients known to be allergic to photosensitizers

Keywords: esophagus cancer photodynamics therapy laser dose
granisteron versus metoclopramide in laparoscopic cholecystectomy

Conditions: Nausea and Vomiting, Postoperative

Summary: study aims at comparing the effect of granisteron with that of metoclopramide in patients undergoing lab cholecystectomy

post operative nausea and vomitting is avery common complication of laparoscopic surgery in that study we will compare between granisteron and metoclopramide as aprophlaxis against post operative nausea and vomitting

Eligibility criteria:
inclusion criteria: * both sexes age between 18 and 60 years asa1 2 3 lap cholecystectomy under general anesthesia exclusion criteria: * patients refusal pregnancy and breastfeeding hepatic or renal disease asa4 5 allergy to the drug

Keywords: laparoscopic cholecystectomy
a randomized trial comparing 2 methods for rapid induction of cooling in stroke patients, cold infusions vs. rhinochill (icool 1)

Conditions: Ischemic Stroke; Hemorrhagic Stroke

Summary: mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling associated cerebrovascular disease. the narrow-time-frame is a major issue ("time is brain"). to provide immediate cooling without delay, easy to use, mobile and effective methods are needed. cold infusions (4 °c) are an accepted standard worldwide. the rhinochill (benechill, usa) is a new device. a comparison of these two induction methods has never been done before. neither was the effect of cold infusions on brain-temperature measured. for the first time icool 1 compares feasibility, safety and efficacy of the two methods.


Eligibility criteria:
inclusion criteria: * sedation, intubation and mechanical ventilation * combined icp-temperature-probe * indication to lower body temperature * age ≥ 18 years exclusion criteria: * body weight \> 120 kg * fever \> 38.5°c * chronic sinusitis * current or past fracture or surgery of the paranasal sinuses * severe infection with bacteremia or sepsis ≤ 72 h * severe renal insufficiency * severe liver insufficiency * acute pulmonary embolism * acute myocardial infarction * severe cardiac insufficiency (nyha ≥ iii) * threatening ventricular dysrhythmia * cardiac dysrhythmia with bradycardia (heart rate \ 450 ms, sick sinus syndrome, av-block ii-iii°). * known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia) * known vasospastic vascular disorder (e.g. raynaud's phenomenon or thromboangiitis obliterans)

Keywords: hypothermia induction of hypothermia cold infusion nasopharyngeal cooling stroke intracranial hemorrhage cerebrovascular disease neuro intensive care
efficacy of a novel multivitamin-mineral supplement in preventing vitamin deficiency in postoperative bariatric patients

Conditions: Bariatric Surgery Candidate

Summary: approximately 33% of the us adult population can be classified as obese based on body mass index. this epidemic of obesity has resulted in over 200,000 bariatric surgeries performed every year for the treatment of "clinically severe obesity". roux-en-y gastric bypass (rygb) is the most common bariatric procedure performed in the united states and has both restrictive and malabsorptive components. despite the success of this procedure in creating long lasting weight loss, vitamin and iron deficiencies are common and can lead to significant morbidity if not appropriately addressed. despite the american association of clinical endocrinologists, the obesity society, and american society for metabolic \& bariatric surgery medical guidelines that include vitamin and mineral supplementation recommendations, there has been very little prospective research conducted to assess the efficacy and compliance of these micronutrient interventions. this prospective randomized controlled clinical study will evaluate the efficacy of a novel vitamin/mineral supplement in decreasing micronutrient deficiencies in post operative bariatric patients.


Eligibility criteria:
inclusion criteria: * ages 18 - 65 years of age * meet appropriate criteria for roux-en-y gastric bypass (rygb) surgery as determined by the principal investigator at the john's hopkins center for bariatric surgery (jhcbs) exclusion criteria: * allergy to a component of the formulations * recent (last 3 months) use of a dietary supplement other than a standard non-bariatric specific multivitamin supplement * documented levels of fat-soluble vitamins (a,d,e,k) or iron above the normal range * pregnant or lactating * expected poor compliance with medical regimen as assessed by jhcbs clinic care providers
a randomized, open-label study of alternative treatment combinations of dideoxycytidine (hivid; ddc) and zidovudine (azt) in patients with hiv infection

Conditions: HIV Infections

Summary: to investigate the appropriate zalcitabine ( dideoxycytidine; ddc ) dose and zidovudine ( azt ) schedule for use in combination therapy in patients with hiv infection.

patients are randomized to one of four treatment arms. ddc is administered at 1 of 2 doses every 8 hours. azt is administered at 1 of 2 doses (every 4 hours while awake or every 8 hours).

Eligibility criteria:
inclusion criteria patients must have: * hiv infection. * cd4 count 100 - 500 cells/mm3.

Keywords: zalcitabine drug therapy, combination acquired immunodeficiency syndrome aids-related complex zidovudine